Iliac Artery Stenting versus Open Surgical Reconstruction for Complex Unilateral Iliac Lesions: a Randomized Trial.

The aim of this study was to compare the safety and effectiveness of endovascular treatment (ET) and open surgical reconstruction (OR) in patients with complex unilateral iliac lesions sparing the common femoral artery.

Materials and methods: From August 2015 till November 2020, eligible patients presenting with steno-occlusive iliac lesions (TASC types C, D) were randomized to either ET or OR. The prespecified primary outcomes were technical success, 30-day primary and secondary patency, and complication rates. Secondary outcomes were major adverse limb events, primary and secondary patency all at 36 months.

Results: Of the 450 patients evaluated, 202 were randomized (101 in the ET group and 101 in the OR group). The average length of hospital stay was shorter in the ET (p<.001). The 30-day postoperative complication rate was 3.96% in the ET group and 15.84% in the OR group (p = .005). The primary patency rates at 36 months were 88.12% in the OR group and 75.25 % in the ET group (HR 0.44, 95% CI 0.22; 0.89, p=.022). Secondary patency at 36 months was 99.01% and 95.05% (HR 0.19, 95% CI 0.02;1.69, p=.13). Amputation free survival at 36 months were 84.16% and 85.15% in OR and ET (HR 1.17, 95% CI 0.54; 2.53, p=.68).

Conclusions: This randomized trial found that ET was associated with a significantly shorter hospital stay and lower rates of postoperative complications, while secondary patency rates up to 3 years were not different. However, the primary patency at 36 months was significantly higher after OR.